Clinical Affairs Manager (part-time)

Wavelet Medical

Remote, US
Rate: $135ph - $175ph; equity: pyrticipytion in br...
Remote
5-10 years clinical experience
Fda medical device regulations knowledge
Clinical trial design and execution
The role involves leading clinical development and driving the adoption of breakthrough fetal monitoring technology to improve maternal and neonatal outcomes

Job Summary

  • The role involves leading clinical development and driving the adoption of breakthrough fetal monitoring technology to improve maternal and neonatal outcomes.
  • Candidates will support the FDA regulatory pathway including Q-sub preparation and oversee clinical data collection for regulatory submissions.
  • The position offers equity participation in a venture-backed medtech company advancing toward FDA clearance of a Class II medical device.

Matching Summary

The role involves leading clinical development and driving the adoption of breakthrough fetal monitoring technology to improve maternal and neonatal outcomes.

Salary

Rate: $135/hour - $175/hour; Equity: Participation in breakthrough medical technology; Benefits: Healthcare benefits included

Skills & Requirements

Must-have

  • 5-10 years clinical experience
  • FDA medical device regulations knowledge
  • Clinical trial design and execution
  • IRB process management
  • Hospital partnership establishment

Nice-to-have

  • Obstetrics or neonatal care background
  • Fetal monitoring technology understanding
  • Experience with academic medical centers
  • Biostatistics and data analysis skills
  • ISO 13485 quality systems familiarity

Key Requirements

  • Advanced degree (MSN, MD, or PhD)
  • Direct experience in obstetrics or women's health
  • Track record of successful regulatory submissions
  • Understanding of healthcare reimbursement challenges

Work Rights

Not specified

Tailored Resume

Cover Letter